Amended regulations regarding the reporting of adverse drug
reactions came into force on February 10, 2011.1 The
objective of the amended regulations is to strengthen the current
adverse drug reaction reporting section of the Food and Drug
Regulations in order to permit more rigorous monitoring of the
safety of drug products by the Minister of Health.
Under the regulations as they were before the amendments came
into force, drug manufacturers were required to submit a case
report to the Minister within 15 days of becoming aware of any
serious adverse reaction associated with a drug. Manufacturers were
also required to prepare annual summary reports on adverse drug
reactions but were not compelled to provide these reports unless
the Minister, after reviewing a manufacturer's case report,
first decided that a particular drug may not be safe.
The amended regulations will now require all drug manufacturers
to immediately notify the Minister in writing if they determine,
while preparing their annual summary reports, that a significant
change has taken place in what was known about the risks and
benefits of the drug during the period covered by the report being
prepared. The Minister may, on the basis of this notification,
request the manufacturer to submit the annual summary report and/or
the adverse drug reaction case reports. The manufacturer must
comply with this request within a reasonable specified period,
determined only after the manufacturer has been provided with an
opportunity to be heard regarding the submission period.
Note that a drug manufacturer that has already notified the
Minister of a significant change in the risks and benefits of a
drug will not have to again notify the Minister regarding the same
The amended regulations also permit the Minister to request an
annual summary and adverse drug reaction case report whenever he or
she decides to examine the safety and effectiveness of the drug. As
in the case of a notification-based request, the Minister requires
the report to be submitted within a specified and reasonable time;
however, if the information is required in order to determine
whether a drug poses a serious and imminent risk to human health,
the Minister may specify a shorter period than 30 days.
Drug manufacturers are now also required to retain records of
the summary reports and adverse drug reaction cases for 25 years
from the date the record was created, instead of the previously
indefinite retention period, in order to provide sufficient time to
develop a safety profile of drugs made available to Canadians.
The amended regulations do not indicate whether the Minister
will publish the manufacturers' reports or summaries on the
Health Canada website. Presumably, the reports may be subject to
access requests via the Access to Information Act
In the United States, drug manufacturers must submit annual
reports to the Food and Drug Administration (FDA) containing a
"brief summary of significant new information from the
previous year that might affect the safety, effectiveness or
labelling of the drug product."2 This is quite
different from the standard imposed by the amended regulations,
which require more frequent and timely reporting in Canada (it is
expected that an average of 10-15 reports would occur per
Note that proposed amendments to the U.S. regulations would
require manufacturers to notify the FDA of safety findings as they
occur. As the Canadian amended regulations have come into force
before any amendments to the U.S. regulations, there may be
significant implications for the pharmaceutical industry. First,
Health Canada may become aware of safety issues before the FDA
does, and so may attempt to drive corrective action. Second, the
fact that a Canadian manufacturer has reported a "significant
change" in the known risks and benefits of a drug may be
alleged to be an admission regarding safety in the context of
product liability litigation. This could spur class action suits
regarding drugs that have been the subject of Canadian adverse
The process for drug manufacturers to notify the Minister
according to the amended regulations will be clarified in guidance
documents issued by Health Canada, and Health Canada's standard
operating procedures for receiving and reviewing case and summary
reports will be altered to allow receipt of the notifications now
required under the amended regulations.
1 Regulations Amending the Food and Drug
Regulations (Adverse Drug Reaction Reporting), C. Gaz.
2011.II. 460, March 2, 2011.
2 Ibid. at 464-465.
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and should not be relied on in that way. Specific advice should be
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